Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

March 23, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Coronary Artery DiseaseOptical Coherence TomographyStent
Interventions
DEVICE

Optical coherence tomography-guided percutaneous coronary intervention

OCT examination is performed using a frequency-domain OCT system (C7 Dragonfly OPTIS Imaging Catheter, Abbott Vascular, Santa Clara, CA, USA) with a 5.4 or 7.5 cm total pullback length according to a non-occlusive technique. The procedure is performed via radial or femoral access with a ≥6 Fr guiding catheter. The OCT catheter is advanced over the 0.014-inch PCI wire and the implanted stent was crossed after administration of intracoronary nitrates of 200 µg. For blood clearing, contrast media was injected through the guiding catheter with an automated power injector. The standard infusion rate was 4 mL/s for 4 seconds with 250 PSI. Follow-up OCT image acquisition was achieved with the same method. After post-PCI OCT, we evaluate the factor regarding post-PCI optimization target by European Expert Consensus.

DEVICE

Optical coherence tomography-guided Onyx family stent expansion

"1. Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure~2. OCT pullback~3. Expansion with over 0.5mm sized non-compliant balloon of each stent~4. OCT pullback~5. Expansion with over 1.0mm sized non-compliant balloon of each stent~6. OCT pullback~7. Expansion with over 1.25\~1.5mm sized non-compliant balloon of each stent~8. OCT pullback~9. Evaluation of polymer status with overexpansion assessed by an electric microscope"

Trial Locations (1)

16995

RECRUITING

Yongin Severance Hospital, Yongin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Severance Hospital

OTHER

collaborator

Medtronic

INDUSTRY

lead

Yonsei University

OTHER

NCT05340361 - Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT | Biotech Hunter | Biotech Hunter